無菌試験市場：試験タイプ別、製品・サービス別、用途別、エンドユーザー別、地域別、機会、予測、2017年～2031年

世界の無菌試験の市場規模は、2024年～2031年の予測期間中に10.73％のCAGRで拡大し、2023年の12億2,000万米ドルから2031年には27億6,000万米ドルに成長すると予測されています。同市場は大幅な成長を遂げており、予測期間中にさらに多様な成長が見込まれます。

医薬品の無菌試験は、医薬品に細菌、真菌、酵母、その他の潜在的に有害な汚染物質を含む生存微生物が存在しないことを確認するために、製薬業界で使用される重要な品質管理プロセスです。無菌試験の主な目的は、医薬品が無菌であり、患者が安全に使用できることを確認することです。この検査プロセスは、微生物の存在が患者に重大な健康リスクをもたらす可能性のある注射剤、眼科製剤、その他の無菌医薬品にとって特に不可欠です。製薬業界は拡大しており、開発中の医薬品や生物製剤の数も増加しています。この成長により、製品の安全性と有効性を確保するための強固な無菌試験の必要性が生じています。

COVID-19パンデミックは、迅速で信頼性の高い無菌試験の重要性を浮き彫りにしました。新たに出現した感染症に対処するため、製薬業界はおそらく今後も検査技術の向上に力を注いでいくとみられています。製薬業界は、その業務において、より多くのことを行うようになってきています。例えば、欧州疾病予防管理センター（ECDC）は2024年1月、病院での滅菌サービスが欧州全体で前年比15％増加したと発表しました。特に外科病棟や集中治療室では、ヘルスケア関連感染（HAI）やCOVID-19の発生を阻止するために厳格な清潔基準を維持する必要性が、この急増の主な原因となっています。この拡大には、標準化された無菌試験手順と地域規制の調和が必要です。遺伝子治療や細胞治療のようなバイオテクノロジーの技術開発は、無菌試験に新たな障害をもたらし、独創的な検査アプローチの創出を刺激します。無菌試験は、製薬企業によって専門の試験受託機関に委託されることが多く、知識へのアクセス、拡張可能な能力、費用対効果が、アウトソーシングの動きを支える主な力となっています。

当レポートでは、世界の無菌試験市場について調査し、市場の概要とともに、試験タイプ別、製品・サービス別、用途別、エンドユーザー別、地域別動向、および市場に参入する企業のプロファイルなどを提供しています。

目次

第1章 プロジェクトの範囲と定義

第2章 調査手法

第3章 エグゼクティブサマリー

第4章 世界の無菌試験市場の見通し、2017年～2031年

• 市場規模の分析と予測
• 市場シェア分析と予測
• 市場マップ分析、2023年
  • 試験タイプ別
  • 製品・サービス別
  • 用途別
  • エンドユーザー別
  • 地域別

第5章 北米の無菌試験市場の見通し、2017年～2031年

第6章 欧州の無菌試験市場の見通し、2017年～2031年

第7章 アジア太平洋の無菌試験市場の見通し、2017年～2031年

第8章 南米の無菌試験市場の見通し、2017年～2031年

第9章 中東・アフリカの無菌試験市場の見通し、2017年～2031年

第10章 需要供給分析

第11章 輸と輸出入の分析

第12章 バリューチェーン分析

第13章 ポーターのファイブフォース分析

第14章 PESTLE分析

第15章 価格分析

第16章 市場力学

• 市場の促進要因
• 市場の課題

第17章 市場の動向と発展

第18章 規制枠組みとイノベーション

第19章 特許の情勢

第20章 ケーススタディ

第21章 競合情勢

• 市場リーダートップ5の競合マトリックス
• 参入企業トップ5のSWOT分析
• 市場の主要参入企業トップ10の情勢
  • Thermo Fisher Scientific Inc.
  • Merck KGaA
  • Charles River Laboratories International, Inc.
  • Satorius AG
  • BioMerieux SA
  • WuXi AppTec Co., Ltd.
  • Pacific BioLabs Inc.
  • Boston Scientific Corporation
  • Samsung Biologics
  • Becton, Dickinson and Company

第22章 戦略的提言

第23章 お問い合わせと免責事項

List of Tables

• Table 1. Pricing Analysis of Products from Key Players
• Table 2. Competition Matrix of Top 5 Market Leaders
• Table 3. Mergers & Acquisitions/ Joint Ventures (If Applicable)
• Table 4. About Us - Regions and Countries Where We Have Executed Client Projects

List of Figures

• Figure 1. Global Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 2. Global Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 3. Global Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 4. Global Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 5. Global Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 6. Global Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 7. Global Sterility Testing Market Share (%), By Region, 2017-2031F
• Figure 8. North America Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 9. North America Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 10. North America Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 11. North America Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 12. North America Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 13. North America Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 14. North America Sterility Testing Market Share (%), By Country, 2017-2031F
• Figure 15. United States Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 16. United States Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 17. United States Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 18. United States Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 19. United States Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 20. United States Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 21. Canada Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 22. Canada Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 23. Canada Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 24. Canada Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 25. Canada Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 26. Canada Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 27. Mexico Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 28. Mexico Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 29. Mexico Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 30. Mexico Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 31. Mexico Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 32. Mexico Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 33. Europe Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 34. Europe Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 35. Europe Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 36. Europe Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 37. Europe Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 38. Europe Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 39. Europe Sterility Testing Market Share (%), By Country, 2017-2031F
• Figure 40. Germany Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 41. Germany Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 42. Germany Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 43. Germany Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 44. Germany Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 45. Germany Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 46. France Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 47. France Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 48. France Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 49. France Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 50. France Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 51. France Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 52. Italy Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 53. Italy Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 54. Italy Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 55. Italy Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 56. Italy Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 57. Italy Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 58. United Kingdom Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 59. United Kingdom Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 60. United Kingdom Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 61. United Kingdom Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 62. United Kingdom Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 63. United Kingdom Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 64. Russia Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 65. Russia Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 66. Russia Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 67. Russia Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 68. Russia Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 69. Russia Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 70. Netherlands Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 71. Netherlands Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 72. Netherlands Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 73. Netherlands Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 74. Netherlands Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 75. Netherlands Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 76. Spain Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 77. Spain Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 78. Spain Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 79. Spain Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 80. Spain Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 81. Spain Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 82. Turkey Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 83. Turkey Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 84. Turkey Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 85. Turkey Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 86. Turkey Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 87. Turkey Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 88. Poland Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 89. Poland Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 90. Poland Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 91. Poland Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 92. Poland Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 93. Poland Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 94. South America Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 95. South America Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 96. South America Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 97. South America Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 98. South America Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 99. South America Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 100. South America Sterility Testing Market Share (%), By Country, 2017-2031F
• Figure 101. Brazil Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 102. Brazil Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 103. Brazil Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 104. Brazil Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 105. Brazil Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 106. Brazil Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 107. Argentina Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 108. Argentina Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 109. Argentina Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 110. Argentina Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 111. Argentina Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 112. Argentina Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 113. Asia-Pacific Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 114. Asia-Pacific Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 115. Asia-Pacific Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 116. Asia-Pacific Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 117. Asia-Pacific Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 118. Asia-Pacific Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 119. Asia-Pacific Sterility Testing Market Share (%), By Country, 2017-2031F
• Figure 120. India Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 121. India Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 122. India Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 123. India Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 124. India Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 125. India Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 126. China Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 127. China Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 128. China Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 129. China Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 130. China Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 131. China Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 132. Japan Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 133. Japan Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 134. Japan Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 135. Japan Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 136. Japan Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 137. Japan Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 138. Australia Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 139. Australia Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 140. Australia Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 141. Australia Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 142. Australia Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 143. Australia Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 144. Vietnam Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 145. Vietnam Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 146. Vietnam Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 147. Vietnam Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 148. Vietnam Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 149. Vietnam Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 150. South Korea Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 151. South Korea Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 152. South Korea Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 153. South Korea Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 154. South Korea Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 155. South Korea Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 156. Indonesia Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 157. Indonesia Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 158. Indonesia Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 159. Indonesia Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 160. Indonesia Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 161. Indonesia Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 162. Philippines Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 163. Philippines Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 164. Philippines Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 165. Philippines Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 166. Philippines Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 167. Philippines Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 168. Middle East & Africa Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 169. Middle East & Africa Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 170. Middle East & Africa Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 171. Middle East & Africa Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 172. Middle East & Africa Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 173. Middle East & Africa Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 174. Middle East & Africa Sterility Testing Market Share (%), By Country, 2017-2031F
• Figure 175. Saudi Arabia Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 176. Saudi Arabia Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 177. Saudi Arabia Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 178. Saudi Arabia Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 179. Saudi Arabia Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 180. Saudi Arabia Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 181. UAE Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 182. UAE Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 183. UAE Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 184. UAE Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 185. UAE Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 186. UAE Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 187. South Africa Sterility Testing Market, By Value, In USD Billion, 2017-2031F
• Figure 188. South Africa Sterility Testing Market, By Volume, In Million Units, 2017-2031F
• Figure 189. South Africa Sterility Testing Market Share (%), By Test Type, 2017-2031F
• Figure 190. South Africa Sterility Testing Market Share (%), By Product and Service, 2017-2031F
• Figure 191. South Africa Sterility Testing Market Share (%), By Application, 2017-2031F
• Figure 192. South Africa Sterility Testing Market Share (%), By End-user, 2017-2031F
• Figure 193. By Test Type Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 194. By Product and Service Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 195. By Application Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 196. By End-user Map-Market Size (USD Billion) & Growth Rate (%), 2023
• Figure 197. By Region Map-Market Size (USD Billion) & Growth Rate (%), 2023

Global sterility testing market is projected to witness a CAGR of 10.73% during the forecast period 2024-2031, growing from USD 1.22 billion in 2023 to USD 2.76 billion in 2031. The market has undergone substantial growth and is expected to further grow manifold during the forecast period.

Pharmaceutical sterility testing is a critical quality control process used in the pharmaceutical industry to ensure that a pharmaceutical product is free from viable microorganisms, including bacteria, fungi, yeast, and other potentially harmful contaminants. The primary objective of sterility testing is to verify that a pharmaceutical product is sterile and safe for patient use. This testing process is especially vital for injectable drugs, ophthalmic preparations, and other sterile pharmaceuticals where the presence of microorganisms can pose significant health risks to patients. The pharmaceutical industry is expanding, with an increasing number of drugs and biologics in development. The growth generates a need for robust sterility testing to ensure product safety and efficacy. The COVID-19 pandemic highlighted the importance of rapid and reliable sterility testing. To address newly emerging infectious diseases, the pharmaceutical sector is probably going to keep concentrating on improved testing techniques. The pharmaceutical industry is becoming more and in its operations. For instance, the European Centre for Disease Prevention and Control (ECDC) stated in January 2024 that hospital sterilization services increased 15% throughout Europe over the previous year. The necessity to uphold strict cleanliness standards to stop Healthcare-Associated Infections (HAIs) and the development of COVID-19, especially in surgical wards and intensive care units, was the main cause of this spike. Standardized sterility testing procedures and regional regulatory harmonization are required for this expansion. Technological developments in biotechnology, such as gene and cell therapies, present novel obstacles for sterility testing and stimulate the creation of creative testing approaches. Sterile testing is frequently contracted out to specialized contract testing laboratories by pharmaceutical corporations. Access to knowledge, scalable capacity, and cost effectiveness are the main forces behind the outsourcing movement.

Rising Prevalence of Infectious Diseases to Lead to Market Expansion

The market for sterility testing has grown dramatically in recent years due to the increased occurrence of infectious diseases. Stricter testing protocols are needed to guarantee the safety and effectiveness of pharmaceuticals, medical devices, and biologics as infectious diseases become more widespread worldwide. Before these medical products are put in the market or given to the patients, sterility testing is essential in ensuring that there are no live germs present. To stop the spread of contagious diseases, governments and regulatory agencies around the world have put strict norms and regulations for the production and testing of medicines and medical equipment. The requirement for sterility testing has increased due to the current regulatory framework as market approval is liable to compliance.

Furthermore, technological developments have increased the accuracy and efficiency of sterility testing methods, increasing their dependability and affordability. These technological developments, support the market's expansion, including automated systems, quick testing procedures, and enhanced detection approaches. In conclusion, sterility testing has become more crucial than ever for guaranteeing product safety and regulatory compliance due to the increased incidence of infectious diseases. As a result, the market for sterility testing has grown as pharmaceutical businesses and healthcare providers place a higher priority on strict quality control procedures to safeguard public health.

For instance, the multidrug-resistant fungus Candida auris caused an outbreak in 2023, which brought attention to the urgent need for improved sterilization services. This bacterium quickly spread throughout healthcare facilities, posing a threat to the effectiveness of current infection control systems. It is known to cause severe infections with high fatality rates. As the Centers for Disease Control and Prevention (CDC) stresses upon the need of strict sterilization procedures to stop its spread, more money has been invested in innovative sterilization technologies. This case demonstrated the critical role sterilization services play in controlling drug-resistant infections that are evolving and propelling market expansion in response to pressing public health concerns.

Technological Development to Fuel Market Growth

Technological developments have greatly increased the sterility testing market's growth by improving the efficacy, precision, and dependability of testing procedures. Robotics and sophisticated instrumentation are examples of automated methods that have simplified the sterility testing procedure, decreasing human error and boosting throughput. Higher testing volumes and faster turnaround times are made possible by these systems, which are essential in sectors, such as biotechnology and pharmaceuticals, where time-to-market is a key. Moreover, quick microbiological testing procedures have been developed using methods such as flow cytometry, adenosine triphosphate (ATP) bioluminescence, and polymerase chain reaction (PCR). When compared to conventional culture-based procedures, these techniques allow faster diagnosis of any possible microbial contamination, which expedites the discharge of products and enhances overall operating efficiency. Improvements in technology have increased the sensitivity of detection, making it possible to identify toxins at low concentrations that may have gone undetected in the past.

This increased sensitivity makes sure that goods go through extensive testing and satisfy strict quality and regulatory criteria. Considering this, the incorporation of innovative technology into sterility testing procedures expands the capacities of testing facilities and bolster market expansion by satisfying the growing need for quicker, more dependable, and effective testing options in the biotechnology, pharmaceutical, and medical device industries. For instance, STEMart, which is a service provider based in the United States, introduced sterility testing services for all medical devices under the guidance of the ISO 11731 in April 2023. This method is called Bioburden Testing, and it estimates the number of microorganisms on the surface of the device whereas their sterility tests suggest, whether the device is sterile.

Pharmaceuticals and Biotechnology Companies to Dominate Amongst End-users

The market for sterility testing is growing due to the pharmaceutical and biological production sector, which is driven by strict regulations and the demand for efficacious and safe products. It is imperative for pharmaceutical businesses to guarantee that their medicines are devoid of microbiological contamination prior to their distribution to end-users, since minute quantities of impurities may jeopardize patient safety and result in legal actions. One of the most important steps in the production of biological and pharmaceutical goods is sterility testing. It confirms that there are no living microbes present, guaranteeing that pharmaceuticals, vaccines, biologics, and medical equipment adhere to the strictest quality and safety requirements. Strict sterility testing techniques are required by regulatory organizations like such as the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, and other organizations across the globe to preserve industry standards and safeguard public health.

Reliable sterility testing services are in greater demand as pharmaceutical and biological firms innovate and broaden their product pipelines to meet the growing concerns of global health. The need for accurate and effective sterility testing techniques is further fueled by developments in biotechnology, personalized medicine, and the complexity of pharmaceutical formulations.

The sterility testing market is primarily driven by the pharmaceutical and biological manufacturing segment, which prioritizes regulatory compliance and upholds the highest standards of product quality and safety. For instance, according to a report, global biopharmaceutical research and development expenditures were projected to reach over 202 billion in 2022. Sterile testing and related services have become more popular over time, which is thought to be the cause of the significant expenditures made in the sector leading to market growth.

North America Dominates the Sterility Testing Market

The market for sterility tests is dominated by North America due to several important reasons that add to the country's market domination. There is a big market for sterility testing goods and services because the pharmaceutical and biotechnology sectors in North America are among the biggest and most developed in the world. Pharmaceutical companies in North America rely extensively on sterility testing to assure the safety, efficacy, and regulatory compliance of their medicines, since they have a strong pipeline of medication candidates, a strong focus on innovation, and substantial investments in research and development. North America enjoys the advantages of an established regulatory framework, due to organizations, such as FDA, that impose strict guidelines on the approval, production, and quality control of drugs. There is a sizable market for sterility testing goods and services as FDA requirements necessitate rigorous sterility testing methodologies, validation studies, and documentation. Sterile testing is crucial for preserving product quality and safety, and this is further supported by the FDA's reputation of strict enforcement and sincerity in regulatory supervision.

Furthermore, the United States leads the world in sterility testing due to the number of top pharmaceutical corporations, contract manufacturing organizations (CMOs), and contract testing laboratories based in the country. These companies make investments in innovative technologies, highly qualified staff, and testing facilities of the highest calibre to satisfy the demanding standards of the pharmaceutical sector and offer complete sterility testing solutions to customers across the globe. Furthermore, the United States has a robust innovation and entrepreneurial culture that supports the creation of innovative sterility testing technology and procedures. The cooperation of established businesses, biotechnology startups, and academic research organizations pushes improvements in automation, fast testing methods, and microbiological detection that improve the effectiveness, precision, and dependability of sterility testing procedures.

For instance, to fulfill the rising demand for sterilization services across food, pharmaceutical, and medical device industries, Sterigenics U.S., LLC dramatically expanded its operations in North America in 2022 by building new facilities and renovating existing ones. Modern sterilization techniques such as ethylene oxide (EtO) and gamma irradiation, which are essential for guaranteeing the security and effectiveness of medical supplies, are now available from Sterigenics U.S., LLC due to this growth.

Future Market Scenario (2024 - 2031F)

Main factors contributing to the anticipated growth of sterility testing market are the rising awareness about patient safety and infection control, increasing prevalence of pathogens and microorganisms, and thus the rising requirement of sterilization services. However, the stringent regulations and rules to ensure certain sterilization processes are going to fuel market growth in the future. As technology is advancing, the market is expected to attain major innovations. Players in this market are expanding at an unparalleled rate, introducing cost-effective and efficient technologies. Government policies and policies made by welfare bodies are greatly fueling the market expansion. For instance, the Rapid System 2.0, an automated sterility testing kit from Milliflex (Merck KGaA), was launched in April 2023. It can calibrate test results in 5 days as opposed to the customary 14 days output. Image analysis, ATP bioluminescence, and membrane filtration are some of the technologies that Milliflex (Merck KGaA) uses. It takes 90 seconds to view these automatic results in 2D and 3D with a thorough analysis.

Key Players Landscape and Outlook

Several companies are expanding their business by planning and adopting new strategies. They are complying with new strategic initiatives regarding the launches of newly developed sterility testing technologies, to help researchers and to strengthen their presence in the market. New product launches, agreements based on contracts, acquisitions and mergers, investments, and partnerships are a few ways through which they are trying to achieve their shares in the market.

For instance, Berkshire Sterile Manufacturing (BSM) is a fill finish Contract Development and Manufacturing Organization (CDMO) for clinical and commercial sterile injectable products located in Massachusetts. In October 2023, Sharp Services, LLC, a leading global provider of clinical trial supply services and commercial pharmaceutical packaging, acquired BSM. Sharp Services, LLC is now able to provide the biopharmaceutical industry with a fully integrated small-to-medium size sterile injectable service offering.

Table of Contents

1. Project Scope and Definitions

2. Research Methodology

3. Executive Summary

4. Global Sterility Testing Market Outlook, 2017-2031F

• 4.1. Market Size Analysis & Forecast
  • 4.1.1. By Value
  • 4.1.2. By Volume
• 4.2. Market Share Analysis & Forecast
  • 4.2.1. By Test Type
    • 4.2.1.1. Rapid Sterility Tests
    • 4.2.1.2. Conventional Sterility Tests
  • 4.2.2. By Product and Service
    • 4.2.2.1. Kits and Reagents
    • 4.2.2.2. Instruments
    • 4.2.2.3. Services
  • 4.2.3. By Application
    • 4.2.3.1. Pharmaceutical and Biopharmaceutical Manufacturing
    • 4.2.3.2. Medical Device Manufacturing
    • 4.2.3.3. Others
  • 4.2.4. By End-user
    • 4.2.4.1. Pharmaceuticals and Biotechnology Companies
    • 4.2.4.2. Hospitals and Clinics
    • 4.2.4.3. Academic and Research Laboratories
    • 4.2.4.4. Others
  • 4.2.5. By Region
    • 4.2.5.1. North America
    • 4.2.5.2. Europe
    • 4.2.5.3. Asia-Pacific
    • 4.2.5.4. South America
    • 4.2.5.5. Middle East and Africa
  • 4.2.6. By Company Market Share Analysis (Top 5 Companies and Others - By Value, 2023)
• 4.3. Market Map Analysis, 2023
  • 4.3.1. By Test Type
  • 4.3.2. By Product and Service
  • 4.3.3. By Application
  • 4.3.4. By End-user
  • 4.3.5. By Region

5. North America Sterility Testing Market Outlook, 2017-2031F*

• 5.1. Market Size Analysis & Forecast
  • 5.1.1. By Value
  • 5.1.2. By Volume
• 5.2. Market Share Analysis & Forecast
  • 5.2.1. By Test Type
    • 5.2.1.1. Rapid Sterility Tests
    • 5.2.1.2. Conventional Sterility Tests
  • 5.2.2. By Product and Service
    • 5.2.2.1. Kits and Reagents
    • 5.2.2.2. Instruments
    • 5.2.2.3. Services
  • 5.2.3. By Application
    • 5.2.3.1. Pharmaceutical and Biopharmaceutical Manufacturing
    • 5.2.3.2. Medical Device Manufacturing
    • 5.2.3.3. Others
  • 5.2.4. By End-user
    • 5.2.4.1. Pharmaceuticals and Biotechnology Companies
    • 5.2.4.2. Hospitals and Clinics
    • 5.2.4.3. Academic and Research Laboratories
    • 5.2.4.4. Others
  • 5.2.5. By Country Share
    • 5.2.5.1. North America
    • 5.2.5.2. Canada
    • 5.2.5.3. Mexico
• 5.3. Country Market Assessment
  • 5.3.1. North America Sterility Testing Market Outlook, 2017-2031F*
    • 5.3.1.1. Market Size Analysis & Forecast
      • 5.3.1.1.1. By Value
      • 5.3.1.1.2. By Volume
    • 5.3.1.2. Market Share Analysis & Forecast
      • 5.3.1.2.1. By Test Type
        • 5.3.1.2.1.1. Rapid Sterility Tests
        • 5.3.1.2.1.2. Conventional Sterility Tests
      • 5.3.1.2.2. By Product and Service
        • 5.3.1.2.2.1. Kits and Reagents
        • 5.3.1.2.2.2. Instruments
        • 5.3.1.2.2.3. Services
      • 5.3.1.2.3. By Application
        • 5.3.1.2.3.1. Pharmaceutical and Biopharmaceutical Manufacturing
        • 5.3.1.2.3.2. Medical Device Manufacturing
        • 5.3.1.2.3.3. Others
      • 5.3.1.2.4. By End-user
        • 5.3.1.2.4.1. Pharmaceuticals and Biotechnology Companies
        • 5.3.1.2.4.2. Hospitals and Clinics
        • 5.3.1.2.4.3. Academic and Research Laboratories
        • 5.3.1.2.4.4. Others
  • 5.3.2. Canada
  • 5.3.3. Mexico

All segments will be provided for all regions and countries covered

6. Europe Sterility Testing Market Outlook, 2017-2031F

• 6.1. Germany
• 6.2. France
• 6.3. Italy
• 6.4. United Kingdom
• 6.5. Russia
• 6.6. Netherlands
• 6.7. Spain
• 6.8. Poland

7. Asia-Pacific Sterility Testing Market Outlook, 2017-2031F

• 7.1. India
• 7.2. China
• 7.3. Japan
• 7.4. Australia
• 7.5. Vietnam
• 7.6. South Korea
• 7.7. Indonesia
• 7.8. Philippines

8. South America Sterility Testing Market Outlook, 2017-2031F

• 8.1. Brazil
• 8.2. Argentina

9. Middle East and Africa Sterility Testing Market Outlook, 2017-2031F

• 9.1. Saudi Arabia
• 9.2. UAE
• 9.3. South Africa
• 9.4. Israel

10. Demand Supply Analysis

11. Import and Export Analysis

12. Value Chain Analysis

13. Porter's Five Forces Analysis

14. PESTLE Analysis

15. Pricing Analysis

16. Market Dynamics

• 16.1. Market Drivers
• 16.2. Market Challenges

17. Market Trends and Developments

18. Regulatory Framework and Innovation

• 18.1. Regulatory Approvals

19. Patent Landscape

20. Case Studies

21. Competitive Landscape

• 21.1. Competition Matrix of Top 5 Market Leaders
• 21.2. SWOT Analysis for Top 5 Players
• 21.3. Key Players Landscape for Top 10 Market Players
  • 21.3.1. Thermo Fisher Scientific Inc.
    • 21.3.1.1. Company Details
    • 21.3.1.2. Key Management Personnel
    • 21.3.1.3. Products and Services
    • 21.3.1.4. Financials (As Reported)
    • 21.3.1.5. Key Market Focus and Geographical Presence
    • 21.3.1.6. Recent Developments/Collaborations/Partnerships/Mergers and Acquisition
  • 21.3.2. Merck KGaA
  • 21.3.3. Charles River Laboratories International, Inc.
  • 21.3.4. Satorius AG
  • 21.3.5. BioMerieux SA
  • 21.3.6. WuXi AppTec Co., Ltd.
  • 21.3.7. Pacific BioLabs Inc.
  • 21.3.8. Boston Scientific Corporation
  • 21.3.9. Samsung Biologics
  • 21.3.10. Becton, Dickinson and Company

Companies mentioned above DO NOT hold any order as per market share and can be changed as per information available during research work.

22. Strategic Recommendations

23. About Us and Disclaimer